Multicenter Clinical Trial Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age, Suffering From Non-productive Cough and Acute Rhinitis.

Ache Laboratorios Farmaceuticos S.A.0 sitesAugust 2011

ConditionsNasal Congestion Cough

InterventionsGroup 1 Group 2

DrugsGroup 1 Group 2

Overview

Phase: Phase 3
Intervention: Group 1
Conditions: Nasal Congestion
Sponsor: Ache Laboratorios Farmaceuticos S.A.
Primary Endpoint: Primary efficacy criteria
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

January 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients over 12 years old, of both sexes;
•Clinical condition compatible with acute rhinitis accompanied by nasal congestion;
•Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;
•Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);
•Score greater than or equal to 2 points on the nasal congestion severity score (As per item 4.1.3);
•If necessary, ICF signed by a parent/representant, or in case the patient over 18 years old, his own signature;
•Patient and/or representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;

Exclusion Criteria

•Non-productive cough with purulent smear, fever (axilar temperature superior than 37,8°C/100°F), purulent runny nose and other signs and symptoms of bacteria infection of upper and lower airways at 7 days before the screening/randomization visit;
•Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;
•Previous diagnosis of asthma;
•Female patients with positive b-HCG;
•Patients under treatment for chronic allergy;
•Presence of purulent or mucupurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
•Current use of systemic antibiotics for any reason;
•Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;
•Participation in last one year of clinical protocols;
•Any psychiatric diseases, including major depression;